FDA Proposes Limit for Inorganic Arsenic in Infant Cereal

The FDA has proposed a limit for inorganic arsenic in infant rice cereal. Arsenic is a naturally occurring element that exists in both organic and inorganic forms. Inorganic arsenic is more toxic to the human body. Consumption of inorganic arsenic is associated with cancer, skin lesions, cardiovascular disease, and diabetes. Poor pregnancy outcomes and neurodevelopment toxicity are also concerns.

In July 2013, the FDA released a draft quantitative assessment of lifetime risk of certain cancers associated with exposure to inorganic arsenic in apple juice. Guidance for industry keeps the level of inorganic arsenic in that product to 10 parts per billion. Rice products are a focus for the FDA because the plant takes up arsenic in the soil as it grows.

Relative to body weight, rice intake for infants, mostly through cereal, is about three times greater than for adults. And people consume the most rice relative to their weight at about 8 months of age.

The FDA is proposing a limit of “action level” of 100 parts per billion for inorganic arsenic in rice cereal. This is parallel to the level set by the European Commission for rice intended for use in food for infants and young children. FDA testing has found that most of the infant rice cereal currently on the market either meets, or is close to, the proposed action level. In fact, the level of inorganic arsenic in almost half of the 76 rice-only cereals for infants were below 100 ppb. Most, or 78%, of those products were at or below 110 ppb inorganic arsenic. All other non-rice foods commonly eaten by infants and toddlers were well below the 100 ppb inorganic arsenic level.

Dr. Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition said in a statement, “our actions are driven by our duty to protect the public health and our careful analysis of the data and the emerging science. The proposed limit is a prudent and achievable step to reduce exposure to arsenic among infants.”

The agency “expects manufacturers can produce infant rice cereal that meet or are below the proposed limit with the use of good manufacturing practices, such as sourcing rice with lower inorganic arsenic levels.” When considering an enforcement action against a manufacturer, the FDA will take this action level into account.

The FDA is not advising the general population to change their current rice consumption based on arsenic in that food, but is providing information to pregnant women and infants to reduce exposure. Rice cereal is a common “starter” food for infants. The agency recommends that rice cereal fortified with iron is a good source of nutrients, but it shouldn’t be the only source, and doesn’t need to be the first food your baby eats. Other fortified infant cereals include oat, barley, and multigrain. The FDA also recommends that pregnant women should consume varied grains, including wheat, oats, and barley, for good nutrition.

In November 2014, Consumer Reports published a story about which rice has the least amount of inorganic arsenic. They found that “rice cereal and rice pasta can have much more inorganic arsenic – a carcinogen – than our 2012 data showed.” At that time, a serving of rice cereal or pasta could put kids “over the maximum amount of rice we recommend they should have in a week.” Their recommendation in 2014 was that babies should eat no more than one serving of infant rice cereal per day, on average.

New research by the FDA found that cooking methods can reduce inorganic arsenic content in rice. Cook rice in lots of water (from six to ten parts of water to one part of rice) and drain off the excess water before serving it. This can reduce 40 to 60% of inorganic arsenic content from the rice, but this method also removes key nutrients from the grain.